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Founder

Stephen Jeong

Founder of Leanabl Inc. Medical device regulatory affairs specialist focused on Korea (MFDS) market entry for foreign manufacturers.

About

Stephen Jeong is the founder of Leanabl Inc., a medical device regulatory consulting firm headquartered in Seoul, South Korea. Leanabl helps foreign medical device manufacturers navigate the Korean MFDS (Ministry of Food and Drug Safety) market entry process — including product registration, KGMP certification, KLH (Korea License Holder) services, post-market vigilance, and HIRA reimbursement listing.

Leanabl is built on three operating principles: No wasted motion (every deliverable answers a regulatory question), The work, not the show (senior practitioners handle engagements directly), and Priced before you commit (transparent fixed-fee pricing where the path is known).

Under Stephen's leadership, Leanabl has structured 17 regulatory services and 13 productized solutions covering the full medical device lifecycle — from regulatory pathway strategy to commercial operations.

Areas of Expertise

Medical Device Regulatory Affairs
MFDS Registration
KGMP Certification
Korea License Holder (KLH)
HIRA Reimbursement
EU MDR Compliance
FDA 510(k) Submissions
ISO 13485 Quality Management
Medical Device Cybersecurity
AI/ML Medical Devices (SaMD)
Post-Market Surveillance

Languages

English · Korean (native)

Work with Leanabl

Looking for regulatory guidance for Korean medical device market entry? Get in touch to discuss your project.

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